The Fosamax® Plaintiffs Have Answered Merck, In The Third Circuit -- On Appeal.

We've literally followed these Fosamax^® (alendronate sodium) products liability cases, involving (in part) non-impact hip fractures. . . now, for going on. . . two decades. And while in the main, Merck has prevailed -- and avoided boxcar liability verdicts, this latest effort may yet break through, in stepping around the Supremes' Wyeth preemption rulings. We shall see.

In any event, here's the Fosamax patients' brief (33 pages, in full), and a bit of it:

. . .FDA’s Complete Response Letter did not render Merck’s compliance with state law impossible. Such letters are provisional, address only the application before FDA, and identify deficiencies for the applicant to correct. FDA told Merck it would not approve Merck’s applications “in their present form” (“stress fracture” warning) and invited Merck to resubmit them to address the deficiencies FDA identified. Merck fails to contend with the Letter’s terms or governing regulations. FDA’s Letter and subsequent agency action confirm that the Letter was a non-final step toward developing an adequate warning, not a prohibition on adding one. . . .

. . .[F]ederal law enabled Merck to comply with its state-law duty to warn adequately of atypical femoral fractures through a “changes being effected” (“CBE”) supplement. 21 C.F.R. § 314.70(c)(6)(iii)(A). Merck and the court err by speculating that FDA would have rejected a CBE’s adequate warning based on FDA’s rejection of Merck’s inadequate warning. A hypothetical conflict cannot preempt state law. FDA’s decision eventually to mandate the warning state law required (after the Task Force fully informed FDA of the proper risk) belies Merck’s claim that FDA informed Merck it would disapprove that warning. . . .

Now you know -- on to Monday, and the celebration/march on the National Mall. Smile. . . .

नमस्ते